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Nanocytology Test to Evaluate Skin Cancer in High Risk Patients

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ClinicalTrials.gov Identifier: NCT01905891
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : November 19, 2014
Sponsor:
Information provided by (Responsible Party):
Joan Guitart, Northwestern University

Brief Summary:
The purpose of this study is to correlate pathological features from specimens in order to determine if this new molecular diagnostic technique can be used to detect risk of skin cancer.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Squamous Cell Carcinoma Procedure: Superficial shave biopsy Not Applicable

Detailed Description:
Squamous cell carcinoma is the culmination of a multistep carcinogenesis process that is preceded by early stages referred as squamous dysplasia and actinic keratosis. Squamous dysplasia (SD) also known as "field effect" is clinically characterized by xerosis (dry, scaly skin), lentigines and uneven pigmentation. While morphologically skin biopsies and cytology samples show only minimal changes, at the molecular level it is known that SD is characterized by small clone keratinocytes carrying mutations of the P53 gene. An optical technology called Partial Wave Spectroscopy (PWS) probes nanoscale structures in the order of tens to a few hundred nanometers. PWS is a light back-scattering techniques that uses light reflected off of a tissue sample. The measured biomarker is sensitive to the cytosolic and nucleic architecture within the cell and quantifies the nanoscale disorder, which conventional light microscopy fails to appreciate. PWS has allowed to identify various grades of structural disorder at the nanoscale level of colonic and pulmonary premalignant cell samples. Using PWS we aim to study the spectrum of cutaneous SD from patients at high risk for SCC development. Since squamous dysplasia is difficult to assess with routine histology and cytopathology and a grading system for squamous dysplasia by routine histology or cytology is not available, we propose to assess the value of PWS as a new and more sensitive imaging technique. By identifying the degree of SD at the molecular level, we may be able to intervene with close surveillance, early treatment and chemoprevention strategies to achieve lower morbidity by means of fewer and smaller skin cancers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Nanocytology Evaluation of Epidermal Cells to Assess Risk of Squamous Cell Carcinoma and Field Cancerization in High Risk Patients
Study Start Date : July 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Skin Cancer

Arm Intervention/treatment
Subjects at risk of skin cancer
Subjects at risk of skin cancer (sun-damaged skin) a superficial shave biopsy will be performed.
Procedure: Superficial shave biopsy
Sample will be obtained from random dorsal forearm skin sites without evidence of keratotic lesions. The site will be selected by the investigator. Skin will first be wiped with an alcohol pad and 1% lidocaine will be superficially infiltrated per standard skin surgical procedures. 30% trichloroacetic acid (TCA, standard chemical peel) will then be applied for five minutes. TCA will be neutralized using bicarbonate. Using a cytology brush (a small brush which is used to collect cells during the course of a biopsy) cells will be collected by gentle scraping surface of the skin. Then, a superficial shave biopsy specimen, obtained by using a dermablade (a flexible, one piece blade specifically designed for shave biopsy and excision of skin lesions) will be obtained.

Subjects with healthy skin
Subjects without sun-damaged skin a superficial shave biopsy will be performed.
Procedure: Superficial shave biopsy
Sample will be obtained from random dorsal forearm skin sites without evidence of keratotic lesions. The site will be selected by the investigator. Skin will first be wiped with an alcohol pad and 1% lidocaine will be superficially infiltrated per standard skin surgical procedures. 30% trichloroacetic acid (TCA, standard chemical peel) will then be applied for five minutes. TCA will be neutralized using bicarbonate. Using a cytology brush (a small brush which is used to collect cells during the course of a biopsy) cells will be collected by gentle scraping surface of the skin. Then, a superficial shave biopsy specimen, obtained by using a dermablade (a flexible, one piece blade specifically designed for shave biopsy and excision of skin lesions) will be obtained.




Primary Outcome Measures :
  1. Nanocytology assessment of skin cancer risk [ Time Frame: 1 year ]
    The primary outcome measure is to correlate clinical phenotype (age, skin phototype, level of photodamage, history of prior skin cancers) with morphology and nuclear characteristics, in order to determine if this new molecular diagnostic technique can be used to detect early stages of skin carcinogenesis and identify high risk-patients.


Secondary Outcome Measures :
  1. Compare nanocytology assessment with pathological findings [ Time Frame: 1 year ]
    Secondary outcome measure is to compare PWS results and clinical phenotype with the evaluation of skin samples by routine cytology/pathology, as they relate to the clinical level of overall photodamaged and prior history of skin cancers.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 89 years old, male and female, Fitzpatrick skin phototype I - III
  • Photodamage skin grades 3 - 4 (global assessment)
  • Medical history of precancerous lesions and or known history of SCC or healthy volunteers

Exclusion Criteria:

  • Subjects under 18 years old
  • Pregnant women or lactating mothers
  • Treatment with systemic chemotherapy within 4 weeks period before consent
  • Known HIV+ patients (self-reported)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905891


Locations
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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Joan Guitart, MD Northwestern University
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Responsible Party: Joan Guitart, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT01905891    
Other Study ID Numbers: JG05012013
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014
Keywords provided by Joan Guitart, Northwestern University:
Non melanoma skin cancer
Field of cancerization
Skin carcinogenesis
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Keratosis, Actinic
Keratosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Skin Diseases
Precancerous Conditions